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Financial Support in an Underserved and Low-Income Population With Heart Failure (FUND-HF)

Primary Purpose

Heart Failure, Systolic, Financial Stress, Medication Adherence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Financial Support
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Systolic focused on measuring social determinants of health

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age > 18 English speaking participants who completed SOCIAL-HF study surveys Ejection Fraction <=40% and eligible for at least one component of GDMT Has at least some difficulty paying monthly bills (Somewhat Difficult and Very Difficult) Annual household income <130% Federal Poverty Limit Have at least two additional social needs based on the following domains: Cost-related nonadherence Food Insecurity Housing Instability Transportation Difficulty Unemployment Household Crowding: Person/Room Ratio >1 Rent Burden: Rent/Income Ratio >30% Low social support Interpersonal Violence History of Discrimination Exclusion Criteria: Unwilling to return for 1 and 2-month follow-up visits. Currently in jail or prison Primary residence outside Dallas County Legal Blindness Systolic blood pressure <90 mmHg on screening Contraindications or Intolerance all medications available for therapeutic drug monitoring (metoprolol, losartan, lisinopril, valsartan, and spironolactone) Unable to answer orientation questions.

Sites / Locations

  • UT Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate Financial Support

Delayed Financial Support

Arm Description

This group will receive $500 at the completion of their baseline visit

This group will receive no financial support at their completion of their baseline visit, but will receive $500 at their 1-month visit.

Outcomes

Primary Outcome Measures

Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)
The first co-primary outcome will be a medication adherence outcome. This will be ascertained using serum therapeutic drug monitoring of guideline directed medical therapies.
Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)
The first co-primary outcome will be a medication adherence outcome. This will be ascertained using serum therapeutic drug monitoring of guideline directed medical therapies.
Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Quality of life will be ascertained using the KCCQ-12, a validated measure of quality of life among patients with heart failure. The score contains four domains, physical limitation, symptom frequency, quality of life, and social limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 denoting the best possible health. These scores are averaged and presented as a summary score.
Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Quality of life will be ascertained using the KCCQ-12, a validated measure of quality of life among patients with heart failure. The score contains four domains, physical limitation, symptom frequency, quality of life, and social limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 denoting the best possible health. These scores are averaged and presented as a summary score.

Secondary Outcome Measures

Self-reported medication adherence by Morisky Medication Adherence Scale
Self-reported medication adherence will be captured by the Morisky Medication Adherence Scale. This scale is an eight-item survey. The score ranges from 0-8, with higher scores denoting greater adherence.
Self-reported medication adherence by Morisky Medication Adherence Scale
Self-reported medication adherence will be captured by the Morisky Medication Adherence Scale. This scale is an eight-item survey. The score ranges from 0-8, with higher scores denoting greater adherence.
Change in social stress
This will be captured using the perceived stress scale. This is a ten-item survey assessing perceived stress over the last month. The scores range from 0-40, with higher scores denoting higher perceived stress.
Change in social stress
This will be captured using the perceived stress scale. This is a ten-item survey assessing perceived stress over the last month. The scores range from 0-40, with higher scores denoting higher perceived stress.

Full Information

First Posted
June 5, 2023
Last Updated
August 29, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05928026
Brief Title
Financial Support in an Underserved and Low-Income Population With Heart Failure
Acronym
FUND-HF
Official Title
Financial Support in an Underserved and Low-Income Population With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to test whether financial support in the form of a one-time $500 stipend would improve medication adherence and quality of life in low-income, socially-needy patients with heart failure with reduced ejection fraction in the post-discharge setting. The main questions it aims to answer are: Will financial support improve medication adherence? Will financial support improve heart failure quality of life? Participants will complete surveys on quality of life, social stress, and spending habits at their baseline visit. Participants will be randomly assigned to receive $500 at their baseline visit or $0 at their baseline visit. At their one month visit, medication adherence and quality of life will be assessed. These results will be compared between groups. The group that received $0 at their baseline visit will be provided $500 at their one-month visit and return for a two-month visit. At that visit, medication adherence and quality of life will be assessed. These results will be compared to their one-month results. Researchers will compare the 1-month medication adherence and quality of life scores between the immediate financial support vs delayed financial support. Researchers will also compare 1-month vs 2-month adherence and quality of life data for participants who were randomized to the delayed financial support group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic, Financial Stress, Medication Adherence, Quality of Life
Keywords
social determinants of health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Financial Support
Arm Type
Experimental
Arm Description
This group will receive $500 at the completion of their baseline visit
Arm Title
Delayed Financial Support
Arm Type
Active Comparator
Arm Description
This group will receive no financial support at their completion of their baseline visit, but will receive $500 at their 1-month visit.
Intervention Type
Behavioral
Intervention Name(s)
Financial Support
Intervention Description
A debit card will be loaded with $500 and can be used like a typical debit card.
Primary Outcome Measure Information:
Title
Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)
Description
The first co-primary outcome will be a medication adherence outcome. This will be ascertained using serum therapeutic drug monitoring of guideline directed medical therapies.
Time Frame
1 month
Title
Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)
Description
The first co-primary outcome will be a medication adherence outcome. This will be ascertained using serum therapeutic drug monitoring of guideline directed medical therapies.
Time Frame
2 months
Title
Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Quality of life will be ascertained using the KCCQ-12, a validated measure of quality of life among patients with heart failure. The score contains four domains, physical limitation, symptom frequency, quality of life, and social limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 denoting the best possible health. These scores are averaged and presented as a summary score.
Time Frame
1 month
Title
Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Quality of life will be ascertained using the KCCQ-12, a validated measure of quality of life among patients with heart failure. The score contains four domains, physical limitation, symptom frequency, quality of life, and social limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 denoting the best possible health. These scores are averaged and presented as a summary score.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Self-reported medication adherence by Morisky Medication Adherence Scale
Description
Self-reported medication adherence will be captured by the Morisky Medication Adherence Scale. This scale is an eight-item survey. The score ranges from 0-8, with higher scores denoting greater adherence.
Time Frame
1 month
Title
Self-reported medication adherence by Morisky Medication Adherence Scale
Description
Self-reported medication adherence will be captured by the Morisky Medication Adherence Scale. This scale is an eight-item survey. The score ranges from 0-8, with higher scores denoting greater adherence.
Time Frame
2 months
Title
Change in social stress
Description
This will be captured using the perceived stress scale. This is a ten-item survey assessing perceived stress over the last month. The scores range from 0-40, with higher scores denoting higher perceived stress.
Time Frame
1 months
Title
Change in social stress
Description
This will be captured using the perceived stress scale. This is a ten-item survey assessing perceived stress over the last month. The scores range from 0-40, with higher scores denoting higher perceived stress.
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Psychologic Stress by Kessler Screening Scale
Description
This is a ten-item instrument measuring psychological distress. Each item has a five-level response scale. The range is 10-50, with higher scores denoting greater psychological distress.
Time Frame
1 Month
Title
Psychologic Stress by Kessler Screening Scale
Description
This is a ten-item instrument measuring psychological distress. Each item has a five-level response scale. The range is 10-50, with higher scores denoting greater psychological distress.
Time Frame
2 months
Title
Number of Emergency Room Visits
Description
This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium
Time Frame
1 Month
Title
Number of Emergency Room Visits
Description
This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium
Time Frame
2 Month
Title
Number of Hospitalizations
Description
This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium
Time Frame
1 Month
Title
Number of Hospitalizations
Description
This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium
Time Frame
2 months
Title
Appointment Completion Rate
Description
This outcome will be captured through review of the electronic medical records
Time Frame
1 Month
Title
Appointment Completion Rate
Description
This outcome will be captured through review of the electronic medical records
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 English speaking participants who completed SOCIAL-HF study surveys Ejection Fraction <=40% and eligible for at least one component of GDMT Has at least some difficulty paying monthly bills (Somewhat Difficult and Very Difficult) Annual household income <130% Federal Poverty Limit Have at least two additional social needs based on the following domains: Cost-related nonadherence Food Insecurity Housing Instability Transportation Difficulty Unemployment Household Crowding: Person/Room Ratio >1 Rent Burden: Rent/Income Ratio >30% Low social support Interpersonal Violence History of Discrimination Exclusion Criteria: Unwilling to return for 1 and 2-month follow-up visits. Currently in jail or prison Primary residence outside Dallas County Legal Blindness Systolic blood pressure <90 mmHg on screening Contraindications or Intolerance all medications available for therapeutic drug monitoring (metoprolol, losartan, lisinopril, valsartan, and spironolactone) Unable to answer orientation questions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ambarish Pandey, MD, MSCS
Phone
214-645-9762
Email
ambarish.pandey@utsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ambarish Pandey, MD,MSCS
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ambarish Pandey, MD,MSCS
Phone
214-645-9762

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Financial Support in an Underserved and Low-Income Population With Heart Failure

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